Drug Regulatory Affairs Specialist (Senior Role)
Drug Regulatory Affairs Specialist (Senior Role)
Novo Nordisk Global Business Services (GBS)
Job description
Looking for a way to help protect patients by scientifically evaluating the safety of medicines? Learn more about the Safety Surveillance Specialist position at Novo Nordisk in Bengaluru, Karnataka.
Company Description
Novo Nordisk is a multinational healthcare business focused on creating medicines for serious chronic conditions. The company is dedicated to scientific innovation and the well-being of patients, seeking to advance health through its medicines and research activities. Its Global Patient Safety teams monitor and assess product safety and partner with colleagues across international sites to promote the development and responsible use of pharmaceuticals.
Job Summary
The Safety Surveillance Specialist post is located in Bengaluru. The Drug Regulatory Affairs Specialist involves analyzing the safety of medicines from clinical development to post-marketing, reviewing safety information, detecting possible signals and supporting benefit-risk assessments. The specialist will also assist risk management strategies, safety documentation and regulatory operations, while working with global teams and external stakeholders to ensure product safety requirements are maintained.
Key Responsibilities
Assess the safety of pharmaceutical products in relation to medical use during clinical development and post-marketing.
Potential dangers should be identified by reviewing safety data from clinical trials, spontaneous reports, scientific literature and other appropriate sources.
Conduct detection, evaluation and interpretation of safety signals to inform evidence-based decision making.
Review scientific literature and integrate pertinent findings into ongoing product safety assessments.
Participate in the creation and implementation of pharmacovigilance strategy and risk management initiatives.
Support benefit-risk evaluations to help guarantee that the benefits of a treatment are continuously weighed against its potential dangers
Support procedures for safety monitoring of clinical research and provide relevant safety-related documentation.
Maintain key reference safety information and support product labeling related operations.
Document scientific safety conclusions accurately in aggregate safety reports and regulatory filings.
Contribute to conversations on safety governance and act as the point of contact for the Safety Surveillance function for interactions with regulatory bodies, consultants and external partners.
Work cross-functionally and with global partners to enable consistent safety reviews and rapid decision-making.
Mentor and coach colleagues; disseminate scientific knowledge; contribute to advances in safety surveillance methods.
Educational Qualification
MBBS or MD degree from a recognized university.
Experience in pharmacovigilance, patient safety or a closely connected subject.
Experience with safety signal management, aggregate safety reporting and Risk Management Plans (RMPs) is a plus.
Skills Required
Strong knowledge of pharmacovigilance and drug safety assessment.
Expertise in identification, evaluation and interpretation of potential safety signals.
Knowledge of drug development procedures and relevant regulatory requirements.
Ability to analyze complex medical and scientific information from a variety of sources.
Familiarity with ideas of benefit-risk assessment and risk management.
Knowledge of product safety paperwork and aggregate safety reports
Strong analytical skills and ability to make evidence-based decisions
Excellent verbal and written English communication abilities.
Ability to effectively manage projects and liaise with interested parties.
Strategic thinking and the ability to see process improvement potential.
Skills in leadership, e.g. the capacity to direct and advise others.
A work attitude that is responsible, ethical, flexible and collaborative.
Salary Structure
A Safety Surveillance Specialist in India earns an average pay of ₹25-30 Lakhs per annum.
Career Development
This role, as a compliance and regulatory officer, provides possibilities to gain experience in pharmacovigilance, safety signal management, risk management and regulatory safety operations. Working with multinational teams can also help you build scientific judgment, stakeholder management and leadership skills.
How to Apply
Visit our job portal and search for Drug Regulatory Affairs Specialist (Senior Role).
Open the listing and read the eligibility criteria and full details about the job.
Complete the essential fields and submit a current copy of your resume.
Submit your application using the official recruitment portal.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.